BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 2812899 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02491
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    January 1, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND THE FAILURE DISAPPEARED DURING ANALYSIS. THE CAUSE FOR THE TELEMETRY AND PACING OUTPUT ANOMALIES IS DUE TO DEPLETED BATTERY VOLTAGE. INITIAL MEASUREMENTS DETERMINED THAT THE DEVICE HAD HIGH CURRENT DRAIN AND REGULATOR SUPPLIES WERE LOWER THAN NOMINAL. THE REPORTED FAILED CONDITIONS WERE SHOWN TO BE RELATED TO THE BATTERY DEPLETION OBSERVATION. HOWEVER, THE LOADED NEGATIVE SUPPLIES CLEARED DURING ANALYSIS AND WERE NOT ABLE TO BE REINTRODUCED. THE DEVICE HIGH CURRENT DRAIN ANOMALY WAS NO LONGER OBSERVED AND THE DEVICE IS FULLY FUNCTIONAL. A MUCH SMALLER CURRENT WAS RE-INTRODUCED ASSOCIATED TO THE CAPACITOR BUT ALSO CLEARED BEFORE A DETERMINATION COULD BE MADE. LONG TERM MONITORING, ELECTRICAL BENCH TESTING, AND TEMPERATURE CYCLING WERE PERFORMED. NO ABNORMAL CONDITIONS WERE OBSERVED. THE REPORTED FAILURES COULD NOT BE REESTABLISHED DURING LAB EVALUATION. THE HYBRID IS FULLY FUNCTIONAL, AND A ROOT CAUSE OF THE FAILURE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WARNING TRIGGERED FOR LOW IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) DEFIB COIL. INFORMATION ALSO INDICATED THERE WAS HIGH RV PACE/SENSE IMPEDANCE. DURING THE LEAD REPLACEMENT PROCEDURE, A NEW LEAD WAS CONNECTED TO THE EXISTING DEVICE WHICH RESULTED IN SIMILAR LOW IMPEDANCE MEASUREMENTS, SO THE DEVICE AND LEAD WERE BOTH EXPLANTED AND REPLACED. INFORMATION INDICATED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R